Device for endoscopic advancement through the small intestine

ABSTRACT

An apparatus for advancing a device through a gastrointestinal tract. In some embodiments, the apparatus includes first and second grabbing mechanisms adapted to grab and release tissue of the gastrointestinal tract, the first grabbing mechanism being releasably attachable to the device, the second grabbing mechanism being attached to an outer element configured to at least partially surround the device, the first and second grabbing mechanisms being axially movable with respect to each other along the gastrointestinal tract; and a radially expandable blocking element disposed proximal to the first grabbing mechanism and movable with the first grabbing mechanism with respect to the second grabbing mechanism, the blocking element being adapted to move tissue of the intestinal tract with respect to the second grabbing mechanism when the blocking element is moved toward the second grabbing mechanism. The invention also includes corresponding methods.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 15/757,230titled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE”,filed Mar. 2, 2018, which is a 371 of PCT/US2016/050290 titled “DEVICEFOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE”, filed Sep. 2,2016, which claims priority to U.S. Provisional Application No.62/213,908, titled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALLINTESTINE”, and filed Sep. 3, 2015, and to U.S. Provisional No.62/339,593, titled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALLINTESTINE”, and filed May 20, 2016, each of which are incorporated byreference herein in their entireties.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

Endoscopic insertion into the small intestine is important, for example,for retrieving foreign bodies, obtaining biopsies, removing smallintestinal tumors or polyps, diagnosing Chron's Disease, performinghemostatis of ulcers, adenomas, arteriovenous malformations, or other GIbleeding, marking for surgeries of the small intestine. However, currentendoscopic procedures cannot quickly and reliably advance through thesmall intestine.

One system for advancing through the small intestine is the FujiFilmDouble Balloon (‘DB’) system, which is used as an adjunct to anendoscope. The DB system consists of a first latex balloon that isattached to a scope tip and a second latex balloon that is attached toan overtube. By sequentially inflating the tip balloon to grab theinside of the small intestine, advancing the deflated overtube balloon,inflating the overtube balloon once it has been full advanced, pullingback on both the overtube and the scope to pleat the intestine,deflating the tip balloon, re-advancing the scope tip, and repeating thecycle, the small intestine can be moved over the endoscope, allowing thesmall intestine to be explored with the scope. However, the DB systemhas numerous drawbacks, resulting in long procedure times, sub-optimalprocedural clinical efficacy, and low professional adoption.

Accordingly, there is an unmet clinical need for a device that permitseasier and faster navigation through the entire length of the smallintestine.

SUMMARY OF THE DISCLOSURE

One aspect of the invention provides an apparatus for advancing a device(such as, e.g., an endoscope) through a gastrointestinal tract, with theapparatus including first and second grabbing mechanisms adapted to graband release tissue of the gastrointestinal tract, the first grabbingmechanism being releasably attachable to the device, the second grabbingmechanism being attached to an outer element configured to at leastpartially surround the device, the first and second grabbing mechanismsbeing axially movable with respect to each other along thegastrointestinal tract; and a radially expandable blocking elementdisposed proximal to the first grabbing mechanism and movable with thefirst grabbing mechanism with respect to the second grabbing mechanism,the blocking element being adapted to move tissue of the intestinaltract with respect to the second grabbing mechanism when the blockingelement is moved toward the second grabbing mechanism.

In some embodiments, the apparatus also includes actuators adapted toactuate the first and second grabbing mechanisms to grab and releasetissue. The apparatus may also include a connecting mechanism configuredto releasably attach the first grabbing mechanism to the device. Theouter element may be an overtube, and the overtube may support actuatorlines extending to the first and second grabbing mechanisms.

In some embodiments, at least one of the first grabbing mechanism andthe second grabbing mechanism comprises a vacuum port. In someembodiments in which the second grabbing mechanism comprises a vacuumport and the device is an endoscope, the apparatus also includes adistal cap adapted to cover a distal end of the endoscope and a sealadapted to seal against an outer surface of the endoscope proximal tothe cap to form a vacuum chamber in fluid communication with a workingchannel of the endoscope and with the vacuum port. The cap may also havean opening adapted to align with the working channel of the endoscopeand a valve disposed in the opening.

In some embodiments, the blocking element comprises a balloon. Theapparatus may also include an overtube attached to the balloon anddefining a balloon inflation channel communicating with an interior ofthe balloon.

In some embodiments, the blocking element comprises a plurality ofradially movable elements. In some embodiments, the blocking element hasa wiping element. In any of the preceding embodiments, the blockingelement is configured to slide over at least a portion of the secondgrabbing mechanism.

Another aspect of the invention provides a method of advancing a devicethrough the gastrointestinal tract including the following steps:inserting a device comprising first and second vacuum ports into thegastrointestinal tract; advancing the first vacuum port distally throughthe gastrointestinal tract; activating vacuum through the first vacuumport to suction tissue of the gastrointestinal tract to the first vacuumport; sliding the second vacuum port towards the first vacuum port whilethe vacuum through the first vacuum port is activated; moving tissueproximally past at least a portion of the second vacuum port using ablocking element that is positioned proximal to the first vacuum port;activating vacuum through the second vacuum port to suction tissue ofthe gastrointestinal tract to the second vacuum port; and releasingvacuum on the first vacuum port to allow the first vacuum port to movefurther distally through the gastrointestinal tract.

In some embodiments, the moving step comprises sliding the blockingelement over the second vacuum port before activating vacuum through thesecond vacuum port. In some embodiments, the blocking element comprisesa balloon.

Some embodiments of the method include the step of expanding theblocking element. Some such embodiments also include the step of keepingthe blocking element expanded during all of the advancing, activatingvacuum through the first vacuum port, sliding, preventing, activingvacuum through the second vacuum port, and releasing steps.

Some embodiments of the invention repeat the steps of advancing,activating vacuum through the first vacuum port, sliding, preventing,and activating vacuum through the second port steps, e.g., until thedevice has moved through a desired distance, such as until the device isentirely through a small intestine of the gastrointestinal tract. Someembodiments of the method include the step of inserting a scope (such asan endoscope) into the device to advance the scope through thegastrointestinal tract as the device advances through thegastrointestinal tract.

Yet another aspect of the invention provides an apparatus for advancingthrough a gastrointestinal tract, with the apparatus including first andsecond grabbing mechanisms adapted to grab and release tissue of thegastrointestinal tract, the first and second grabbing mechanisms beingaxially movable with respect to each other along the gastrointestinaltract; and a radially expandable blocking element disposed proximal tothe first grabbing mechanism and movable with the first grabbingmechanism, the blocking element being adapted to enable tissue of theintestinal tract to move with respect to second grabbing mechanism. Insome embodiments, the apparatus also includes actuators adapted toactuate the first and second grabbing mechanisms to grab and releasetissue.

In some embodiments, the first grabbing mechanism is attachable to aninner element and the second grabbing mechanism is attached to an outerelement configured to at least partially surround the inner element.Some such embodiments also include a connecting mechanism configured toreleasably attach the first grabbing mechanism to the inner element. Theinner element may be, e.g., an endoscope, and the outer element may be,e.g., an overtube. In embodiments with an overtube, the overtube maysupport actuator lines extending to the first and second grabbingmechanisms.

In some embodiments, at least one of first grabbing mechanism and secondgrabbing mechanism comprises a vacuum port. In some embodiments, thesecond grabbing mechanism comprises a vacuum port and the device is anendoscope, with the apparatus further comprising a distal cap adapted tocover a distal end of the endoscope and a seal adapted to seal againstan outer surface of the endoscope proximal to the cap to form a vacuumchamber in fluid communication with a working channel of the endoscopeand with the vacuum port. In some such embodiments, the apparatus alsomay include an opening in the cap adapted to align with the workingchannel of the endoscope and a valve disposed in the opening.

In some embodiments, the blocking element comprises a balloon. Some suchembodiments also include an overtube attached to the balloon anddefining a balloon inflation channel communicating with an interior ofthe balloon.

In some embodiments, the blocking element comprises a plurality ofradially movable elements. In some embodiments, the blocking mechanismcomprises a wiping element. In any of the preceding embodiments, theblocking element may be configured to slide over at least a portion ofthe second grabbing mechanism.

Yet another aspect of the invention provides a method of advancing adevice through the gastrointestinal tract, with the method including thefollowing steps: inserting a device comprising first and second portsinto the gastrointestinal tract; advancing the first port distallythrough the gastrointestinal tract away from the second port; slidingthe second port towards the first port; moving tissue proximally pastthe second port using a blocking element that is positioned proximal tothe first port; activating vacuum through the second port to suctiontissue of the gastrointestinal tract to the second port; and advancingthe first port distally through the gastrointestinal tract while thevacuum is activated through the second port.

Some embodiments of the method include the step of sliding the blockingelement over the second port before activating vacuum through the secondport. In some embodiments, the blocking element comprises a balloon.

Some embodiments of the method include the step of expanding theblocking element. Some such embodiments also include the step of keepingthe blocking element expanded during all of the advancing, sliding,preventing, and activating, steps.

Some embodiments of the method repeat the steps of sliding, preventing,activating, and advancing the first port distally through thegastrointestinal tract while the vacuum is activated through the secondport, e.g., until the device has moved through a desired distance, suchas entirely through a small intestine of the gastrointestinal tract.

Some embodiments of the method include the step of inserting a scopeinto the device to advance the scope through the gastrointestinal tractas the device advances through the gastrointestinal tract.

Still another aspect of the invention provides a method of advancing adevice through the gastrointestinal tract, the method including thefollowing steps: inserting a device having a first grabbing mechanismand a second grabbing mechanism into the gastrointestinal tract;activating the first grabbing mechanism to grab tissue of thegastrointestinal tract; moving the first and second grabbing mechanismstowards each other; using a blocking element to urge tissue of thegastrointestinal tract proximal to the second grabbing mechanism duringthe moving step; activating the second grabbing mechanism to grab tissueof the gastrointestinal tract; deactivating the first grabbingmechanism; and advancing the first grabbing mechanism distally while thesecond grabbing mechanism is activated. In some embodiments, at leastone of the first and second grabbing mechanisms is a vacuum port.

Some embodiments of the method include the step of sliding the blockingelement over the second grabbing mechanism before activating the secondgrabbing mechanism. In some such embodiments, sliding the blockingelement over the second grabbing mechanism urges pleated tissue of thegastrointestinal tract proximally over the second grabbing mechanism.

In some embodiments, the blocking element comprises a balloon. Someembodiments include the step of expanding the blocking element. In somesuch embodiments, the blocking element is kept expanded during all ofthe steps of activating the first grabbing mechanism, moving,preventing, activating the second grabbing mechanism, deactivating, andadvancing steps.

Some embodiments of the method include the step of deactivating thesecond grabbing mechanism after advancing the first grabbing mechanismdistally. Some embodiments of the method repeat the steps of activatingthe first grabbing mechanism, moving, preventing, activating the secondgrabbing mechanism, deactivating the first grabbing mechanism, advancingthe first grabbing mechanism, and deactivating the second grabbingmechanism until the device has been advanced a desired distance, e.g.,until the device is entirely through a small intestine of thegastrointestinal tract.

Some embodiments of the method include the step of inserting a scopeinto the device to advance the scope through the gastrointestinal tractas the device advances through the gastrointestinal tract.

Yet another aspect of the invention provides a method of advancing adevice through the gastrointestinal tract, with the method including thefollowing steps: inserting a device having a first grabbing mechanismand a second grabbing mechanism into the gastrointestinal tract;activating the first grabbing mechanism to grab tissue of thegastrointestinal tract; moving the first and second grabbing mechanismstowards each other to create pleats of tissue therebetween; moving thepleats of tissue proximal to a portion of the second grabbing mechanism;activating the second grabbing mechanism to grab tissue of thegastrointestinal tract that is distal to substantially all of the pleatsof tissue; and advancing the first grabbing mechanism distally while thesecond grabbing mechanism is activated. In some embodiments, at leastone of the grabbing mechanisms is a vacuum port.

Some embodiments of the method include the step of moving tissueproximally past the second grabbing mechanism using a blocking elementthat is positioned proximal to the first grabbing mechanism. Some suchmethods also include the step of sliding the blocking element over thesecond grabbing mechanism before activating the second grabbingmechanism. Sliding the blocking element over the second grabbingmechanism may urge pleated tissue of the gastrointestinal tractproximally over the second grabbing mechanism. In some embodiments, theblocking element comprises a balloon. In some embodiments, the methodmay include the step of expanding the blocking element. The blockingelement may be kept expanded throughout all of the steps of activatingthe first grabbing mechanism, moving the first and second grabbingmechanisms, moving the pleats of tissue, activating the second grabbingmechanism, and advancing the first grabbing mechanism.

Some embodiments of the method repeat the steps of activating the firstgrabbing mechanism, moving the first and second grabbing mechanisms,moving the pleats of tissue, activating the second grabbing mechanism,and advancing the first grabbing mechanism, e.g., until the device hasmoved through a desired distance, such as entirely through a smallintestine of the gastrointestinal tract.

Some embodiments of the method include the step of inserting a scopeinto the device to advance the scope through the gastrointestinal tractas the device advances through the gastrointestinal tract. In someembodiments, the step of moving the pleats of tissue proximal to aportion of the second grabbing mechanism comprises sliding an element ofthe device over the second grabbing mechanism.

In general, in one embodiment, a method of advancing a device throughthe gastrointestinal tract, includes: (1) inserting a device comprisingfirst and second vacuum ports into the gastrointestinal tract; (2)advancing the first vacuum port distally through the gastrointestinaltract; (3) activating vacuum through the first vacuum port to suctiontissue of the gastrointestinal tract to the first vacuum port; (4)sliding the second vacuum port towards the first vacuum port while thefirst vacuum port is activated; (5) preventing tissue from movingdistally past a blocking element that is positioned proximal to thefirst vacuum port; (6) activating vacuum through the second vacuum portto suction tissue of the gastrointestinal tract to the second port; (7)releasing vacuum on the first vacuum port; and (8) advancing the firstvacuum port distally through the gastrointestinal tract.

This and other embodiments can include one or more of the followingfeatures. The method can further include sliding the blocking elementover the second vacuum port before activating vacuum through the secondvacuum port. Sliding the blocking element over the second vacuum portcan urge pleated tissue of the gastrointestinal tract proximally overthe second vacuum port. The blocking element can include a balloon. Themethod can further include expanding the blocking element. The methodcan further include keeping the blocking element expanded throughout anentire advancement procedure.

In general, in one embodiment, a method of advancing a device throughthe gastrointestinal tract, includes: (1) inserting a device comprisingfirst and second ports into the gastrointestinal tract; (2) advancingthe first port distally through the gastrointestinal tract away from thesecond port; (3) sliding the second port towards the first port; (4)preventing tissue from moving distally past the a blocking element thatis positioned proximal to the first port; (5) activating vacuum throughthe second port to suction tissue of the gastrointestinal tract to thesecond port; and (6) advancing the first port distally through thegastrointestinal tract.

This and other embodiments can include one or more of the followingfeatures. The method can further include sliding the blocking elementover the second port before activating vacuum through the second vacuumport. Sliding the blocking element over the second port can urge pleatedtissue of the gastrointestinal tract proximally over the vacuum port.The blocking element can include a balloon. The method can furtherinclude expanding the blocking element. The method can further includekeeping the blocking element expanded throughout an entire advancementprocedure.

In general, in one embodiment, a device for advancing a scope throughthe gastrointestinal tract includes a first vacuum, a second vacuum anda blocking element proximal to the first vacuum port. A first vacuumport is configured to maintain a fixed position relative to the scope. Asecond vacuum port is configured to slide relative to the first vacuumport. The blocking element proximal to the first vacuum port includes aradially expandable portion.

This and other embodiments can include one or more of the followingfeatures. The first vacuum port or the second vacuum port can furtherinclude a plurality of vacuum holes extending therearound. The blockingelement can be a balloon. The blocking element can be configured toslide over at least a portion of the second vacuum port.

In general, in one embodiment, a method of advancing a device throughthe gastrointestinal tract includes: (1) inserting a device having afirst grabbing mechanism and a second grabbing mechanism into thegastrointestinal tract; (2) activating the first grabbing mechanism tograb tissue of the gastrointestinal tract; (3) moving the first andsecond grabbing mechanisms towards each other; (4) preventing tissue ofthe gastrointestinal tract from moving distally past the first grabbingmechanism with a blocking element; (5) activating the second grabbingmechanism to grab tissue of the gastrointestinal tract; (6) deactivatingthe first grabbing mechanism; and (7) advancing the first grabbingmechanism distally while the second grabbing mechanism is activated.

This and other embodiments can include one or more of the followingfeatures. At least one of the grabbing mechanisms can be a vacuum port.The method can further include sliding the blocking element over thesecond grabbing mechanism before activating the second grabbingmechanism. Sliding the blocking element over the second vacuum port canurge pleated tissue of the gastrointestinal tract proximally over thesecond grabbing mechanism. The blocking element can include a balloon.The method can further include expanding the blocking element. Themethod can further include keeping the blocking element expandedthroughout an entire advancement procedure.

In general, in one embodiment, a device for advancing a scope throughthe gastrointestinal tract includes a first tissue grabbing mechanism, asecond tissue grabbing mechanism and a blocking element proximal to thefirst grabbing mechanism. A first tissue grabbing mechanism isconfigured to maintain a fixed position relative to the scope. A secondtissue grabbing mechanism is configured to slide relative to the firsttissue grabbing mechanism. A blocking element proximal to the firstgrabbing mechanism includes a radially expandable portion.

This and other embodiments can include one or more of the followingfeatures. The blocking element can be configured to slide over at leasta portion of the second tissue grabbing mechanism. The blocking elementcan be a balloon. The first grabbing mechanism or the second grabbingmechanism can be a vacuum port.

In general, in one embodiment, a method of advancing a device throughthe gastrointestinal tract includes: (1) inserting a device having afirst grabbing mechanism and a second grabbing mechanism into thegastrointestinal tract; (2) activating the first grabbing mechanism tograb tissue of the gastrointestinal tract; (3) moving the first andsecond grabbing mechanisms towards each other to create pleats of tissuetherebetween; (4) moving the pleats of tissue proximal to a portion ofthe second grabbing mechanism; (5) activating the second grabbingmechanism to grab tissue of the gastrointestinal tract that is distal tosubstantially all of the pleats of tissue; and (6) advancing the firstgrabbing mechanism distally while the second grabbing mechanism isactivated.

This and other embodiments can include one or more of the followingfeatures. At least one of the grabbing mechanisms can be a vacuum port.The method can further include preventing tissue of the gastrointestinaltract from moving distally past the first grabbing mechanism with ablocking element. The method can further include sliding the blockingelement over the second grabbing mechanism before activating the secondgrabbing mechanism. Sliding the blocking element over the second vacuumport can urge pleated tissue of the gastrointestinal tract proximallyover the second grabbing mechanism. The blocking element can include aballoon. The method can further include expanding the blocking element.The method can further include keeping the blocking element expandedthroughout an entire advancement procedure. Moving the pleats of tissueproximal to a portion of the second grabbing mechanism can includesliding an element of the device over the second grabbing mechanism.

In general, in one embodiment, a device for advancing a scope throughthe gastrointestinal tract includes a first vacuum port, a second vacuumport, and a blocking element configured to slide over a portion of thesecond vacuum port. A first vacuum port is configured to maintain afixed position relative to the scope. A second vacuum port is configuredto slide relative to the first vacuum port.

This and other embodiments can include one or more of the followingfeatures. The first vacuum port or the second vacuum port can furtherinclude a plurality of vacuum holes extending therearound. The blockingelement can be a balloon. The blocking element can be configured toslide over at least a portion of the second vacuum port.

In general, in one embodiment, a device for advancing a scope throughthe gastrointestinal tract includes a blocking element and a vacuumport. A blocking element is configured to be in a fixed positionrelative to the scope. The blocking element includes a radiallyexpandable portion. A vacuum port is configured to slide relative to thefirst blocking element.

This and other embodiments can include one or more of the followingfeatures. The first vacuum port can include a plurality of vacuum holesextending therearound. The blocking element can be a balloon. Theblocking element can be configured to slide over at least a portion ofthe vacuum port.

In general, in one embodiment, a device for advancing a scope throughthe gastrointestinal tract includes a blocking element and a grabbingmechanism proximal to the blocking element. A blocking element isconfigured to be in a fixed position relative to the scope. The blockingelement includes a radially expandable portion. A grabbing mechanismproximal to the blocking element is configured to slide over at least aportion of the grabbing mechanism.

This and other embodiments can include one or more of the followingfeatures. The grabbing mechanism can be a vacuum port. The blockingelement can be a balloon. The blocking element can be configured toslide over at least a portion of the second vacuum port.

In general, in one embodiment, a device for advancing an endoscopethrough the gastrointestinal tract includes a vacuum port attached to anovertube. The overtube is configured to be positioned around a scope.The overtube is configured to create a reciprocating closed volume andvacuum seal between an inner circumference of the overtube and the outercircumference of the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-1C show various views of a device for endoscopic advancementthrough the small intestine.

FIGS. 2A-2B show various views of a distal vacuum port of a device forendoscopic advancement through the small intestine.

FIGS. 3A-3D show various views of another embodiment of a distal vacuumport.

FIG. 4 shows another embodiment of a distal vacuum port.

FIG. 5 shows another embodiment of a distal vacuum port.

FIG. 6 shows another embodiment of a distal vacuum port.

FIGS. 7A-7C show various views of another embodiment of a distal vacuumport.

FIGS. 8A-8E show various views of a blocking element of a device forendoscopic advancement through the small intestine.

FIGS. 9A-9C show various views of a strut of a blocking element.

FIGS. 10A-10B show various views of a seal of a blocking element.

FIG. 11 shows a strut and a return spring of a blocking element.

FIGS. 12A-G show an exemplary method of activating a blocking element.

FIGS. 13A-13B show various views of another embodiment of a blockingelement.

FIGS. 14A-14B show various views of another embodiment of a blockingelement.

FIG. 15 shows another embodiment of a blocking element.

FIGS. 16A-16D show various views of another embodiment of a blockingelement.

FIG. 17 shows another embodiment of a blocking element.

FIGS. 18A-18D show various views of another embodiment of a blockingelement.

FIGS. 19A-19D show various embodiments of overtubes of a device forendoscopic advancement through the small intestine.

FIGS. 20A-20B show various views of one mechanism for attaching atelescoping vacuum tube to the outer tube of a device for endoscopicadvancement through the small intestine.

FIGS. 21A-21C show various views of another mechanism for attaching atelescoping vacuum tube to the outer tube of a device for endoscopicadvancement through the small intestine.

FIG. 22 shows an embodiment of a telescoping vacuum tube attached to theouter tube of a device for endoscopic advancement through the smallintestine.

FIG. 23 shows another embodiment of a telescoping vacuum tube attachedto the outer tube of a device for endoscopic advancement through thesmall intestine.

FIGS. 24A-24B show different modes of extending the distal vacuum linefrom the distal vacuum port.

FIGS. 25A-C show various views of a handle for a device for endoscopicadvancement through the small intestine.

FIGS. 26A-26C show various views of a handle for a device for endoscopicadvancement through the small intestine.

FIGS. 27A-27B show a cross-section of a spool valve for a handle for adevice for endoscopic advancement through the small intestine.

FIG. 28 shows another embodiment of a blocking element of a device foradvancement through the small intestine.

FIGS. 29A-E show attachment of a device for endoscopic advancement to anendoscope.

FIGS. 30A-30H show use of a device for endoscopic advancement in thesmall intestine.

FIGS. 31A-F show use of a device for endoscopic advancement in the smallintestine.

FIGS. 32A-G show an embodiment of a device for endoscopic advancementhaving an inflatable blocking element.

FIGS. 33A-33C show a distal vacuum port including axially extending armsfor increased flexibility.

FIGS. 34A-34C show another embodiment of a distal vacuum port includingaxially extending arms for increased flexibility.

FIGS. 35A-C show a distal vacuum port including laser-cut coils forincreased flexibility.

FIGS. 36A-36C show a distal vacuum port including annular linksconnected with wire joints for increased flexibility.

FIGS. 37A-37C show another embodiment of a distal vacuum port includingannular links connected with wire joints for increased flexibility.

FIGS. 38A-38C show a distal vacuum port including living hinges forincreased flexibility.

FIGS. 39A-39D shows a device for endoscopic advancement in the smallintestine with the blocking element axially spaced away from the distalvacuum port.

FIGS. 40A-40C show a proximal vacuum port including a single wall.

FIG. 41 shows another embodiment of a proximal vacuum port including asingle wall.

FIGS. 42A-42B show a proximal vacuum port including two arrays of holes.

FIGS. 43A-43B show another embodiment of a proximal vacuum port.

FIGS. 44A-44D show a proximal vacuum port formed as an extension of theovertube.

FIG. 45 shows a proximal vacuum port with a reinforcement coil.

FIG. 46 shows a sealed space between the endoscope and the overtube.

FIGS. 47A-I show a device having an extendable needle for inflation of aballoon blocking element.

FIGS. 48A-D show another embodiment of a device having an extendableneedle for inflation of a balloon blocking element.

FIGS. 49A-B show a distal vacuum port including an indicator element forindicating proper docking of the proximal vacuum port within theblocking element.

FIGS. 50A-F show an exemplary wiping element.

FIGS. 51A-F show another exemplary wiping element.

FIGS. 52A-F show an exemplary blocking element.

FIGS. 53A-53H show an exemplary handle for controlling inflation of theproximal vacuum port.

FIGS. 54A-D show a portion of an exemplary handle for controllinginflation of the proximal vacuum port.

FIGS. 55A-C show an exemplary valve on the end of the working channel ofa scope.

FIGS. 56A-D show an exemplary proximal vacuum port with ribs extendingon the inner circumference and circular holes.

FIGS. 57A-D show an exemplary proximal vacuum port with ribs extendingon the inner circumference and rectangular holes.

FIGS. 58A-C show another example of a balloon blocking element.

FIG. 59 shows another embodiment of a device for endoscopic advancementthrough the small intestine.

FIG. 60 shows another embodiment of a device for endoscopic advancementthrough the small intestine.

FIGS. 61A-61C show various designs for a dual overtube device forendoscopic advancement through the small intestine.

FIGS. 62A-B show various views of another embodiment of a device forendoscopic advancement through the small intestine.

FIGS. 63A-B show various views of another embodiment of a device forendoscopic advancement through the small intestine.

FIG. 64 shows another embodiment of a device for endoscopic advancementthrough the small intestine.

FIG. 65 shows an exemplary system lay-out.

FIGS. 66A-H show another embodiment of a device for endoscopicadvancement through the small intestine that includes an overtubeconnected to a balloon blocking element for inflation thereof.

FIG. 67 shows a device for endoscopic advancement through the smallintestine with an inflatable element on the proximal vacuum port.

FIG. 68 shows a device for endoscopic advancement through the smallintestine wherein the proximal vacuum port is replaced with aninflatable element.

FIGS. 69A-69C show various radial expansion mechanisms for a blockingelement.

FIGS. 70A-70B show another embodiment of a proximal vacuum port.

DETAILED DESCRIPTION

In general, the devices described herein are configured to allow anendoscope or other device to travel through the small intestine. Thedevices include first and second grabbing mechanisms, such as vacuumports, that are slideable relative to one another and can besequentially activated to grab and release tissue of the smallintestine. The devices can further include a blocking element thatpushes grabbed tissue proximally, plicating the tissue, and ensuringefficient movement of the device and endoscope through the smallintestine.

Referring to FIGS. 1A-1C, an exemplary device 100 is configured to rideover an interior element, such as endoscope 101. Other interior elementsmay be used with the advancement apparatus of this invention, such assheaths, tools, etc. The device 100 includes a distal vacuum port 102and a proximal vacuum port 103. The distal vacuum port 102 is configuredto attach to the endoscope 101 while the proximal vacuum port 103 isattached to an overtube 104 that extends over the endoscope 101.Further, the vacuum ports 102/103 are configured to be axially slideablerelative to one another (see, e.g., the transition from FIG. 1A to FIG.1C). A telescoping vacuum line 105 extends from the distal vacuum port102 and through the overtube 104. Further, another vacuum line 106extends to the proximal vacuum port 103. The device 100 further includesa blocking element 222 axially movable with, and proximal to, the distalvacuum port 102 that is configured to expand upon activation by axialmovement of the proximal vacuum port 103. A handle 107 controls therelative movement of the ports 102, 103, the blocking element 222, aswell as the vacuum applied thereto through the vacuum lines 105, 106.

Referring to FIG. 31A-31F, another exemplary device 3100 is configuredto ride over an endoscope 3100 for advancement of the scope through alumen 3131, such as the small intestine. The device 3100 is similar todevice 100 and includes a distal vacuum port 3102 and a proximal vacuumport 3103. The distal vacuum port 3102 in this configuration, however,is attached to the very tip of the endoscope 3101 while the proximalvacuum port 3103 is attached to an overtube 3104 that extends over theendoscope 3101. The vacuum ports 3102/3103 are configured to be axiallyslideable relative to one another, as described with respect to device100. The device 3100 further includes a support 3110 extending connectedto, and proximally from, the distal vacuum port 3102 and a blockingelement 3122 connected to support 3110 proximal to the distal vacuumport 3102 so that blocking element 3122 and distal vacuum port 3102 movetogether with the endoscope 3101. The blocking element 3222 in thisembodiment is an inflatable balloon, and the proximal vacuum port 3103is configured to slide thereunder when the endoscope 3101 is drawnproximally with respect to the overtube 3104.

Grabbing Mechanisms/Vacuum Ports

The devices described herein can include a distal grabbing mechanismconfigured to grab tissue, such as a distal vacuum port, and a proximalgrabbing mechanism configured to grab tissue, such as a proximal vacuumport. The proximal and distal grabbing mechanisms can be movablerelative to one another. Many of the embodiments described hereininclude vacuum grabbing mechanisms. However, for any of theseembodiments, the proximal and/or distal vacuum grabbing mechanism can bereplaced with an inflatable element, such as a balloon. Further,although many of the embodiments described herein include two grabbingmechanisms, the devices can be used with only one grabbing mechanism,such as only the proximal grabbing mechanism.

Distal Vacuum Port

The distal vacuum port can be configured to connect to the scope and/orremain fixed axially relative to the scope. In some embodiments, asshown in FIG. 1A-1C, the distal vacuum port 102 can be configured toattach to the endoscope 101 just proximal to the steerable section ofthe scope, such as just proximal to the bump created at the connectionbetween the steerable and flexible sections. In this embodiment, theport 102 leaves the steerable section substantially uncovered. In otherembodiments, referring to FIGS. 32A-32C, the distal vacuum port 3202 canbe configured to attach over the distal-most tip of the endoscope 3201(see also device 3100 in FIGS. 31).

Referring to FIGS. 2A-2B, in some embodiments, a connecting mechanism123, such as a split collet, can allow the distal vacuum port 102 toclamp around the endoscope. The connecting mechanism 123 can furtherinclude mating threads 145, 147 that, when rotated relative to oneanother, tighten the distal vacuum port 102 around the endoscope.Alternative attachment mechanisms include set screws or interference fitparts. Referring to FIGS. 32A-G, in some embodiments, the distal vacuumport 3202 can be attached with a shear clip 3245 (see FIG. 32E), whichcan be placed within a feature 3246 (see FIGS. 32D-E) that prevents theclip from coming dislodged. Other mechanisms of attachment are possible,such as a split clamp or set screws (see FIGS. 33A-33C) or anelastomeric band.

In some embodiments, the distal vacuum port can include a double walledport, where vacuum is created between the walls. For example, referringto FIGS. 2A-2B, the distal vacuum port 102 includes an inner cylindricalportion 202 b and an outer cylindrical portion 202 a and a sealed space220 therebetween. A plurality of holes 230 extend through the outercylindrical portion 202 a into the sealed space 220. Further, the vacuumline 105 extends into the sealed space 220 to provide vacuum thereto.The holes 230 can be arranged along the outer circumference of the outercylindrical portion 202 a. The holes 230, which can be circular, canfurther be arranged as an array around the circumference of the outercylindrical portion 202 a. In one embodiment, there can be fivecircumferential rows of holes 230.

In other embodiments, the distal vacuum port can include a singledwalled port, where vacuum is created between the single wall and thescope. Thus, for example, as shown in FIGS. 32A-32C, the distal vacuumport 3202 can be sealed to the scope 3201 with an end cap 3296 and ano-ring 3271 a or sealing cartridge so as to provide a sealed vacuumchamber between the single wall of the distal vacuum port 3202 and thescope 3201. Holes 3230 extending through the wall of the port 3202 allowfor suction of the tissue thereto.

In some embodiments, the distal vacuum port can include linkages thereinto ensure that the distal tip of the endoscope can still flex or movewithout hindrance from the distal vacuum port. The linkages can thus goover the steering section of the endoscope without impeding its nativeability to articulate, thereby allowing the distal vacuum port to beplaced at the end of the scope (as shown in FIGS. 32A-32C). The linkagescan also be useful if the distal vacuum port is placed at a moreproximal location by allowing the scope to more easily flex as, forexample, it bends within a tight radius inside of the patient. Thearticulating sections can withstand and/or accommodate torsion, tension,and compression and can have low bending force.

For example, referring to FIGS. 33A-33C, the distal vacuum port 3302 caninclude axially extending arms 333 having a vacuum passage therethrough,which can enhance the flexibility of the distal tip 3302. FIGS. 34A-34Cshow another distal vacuum port 3402 includes long axially extendingarms 3434. In contrast to the port 3302 of FIGS. 33A-33C, the port 3402includes a single wall vacuum design, allows for sealing around theinflation port of the scope for inflation of a blocking element, andattaches with a shear clip rather than set screws. Referring to FIGS.35A-35C, as another example, the distal vacuum port 3502 includeslaser-cut coils 3535 extending therearound to enhance flexibility.Referring to FIGS. 36A-36C, as another example, the distal tip 3602 caninclude annular plastic links 3661 connected together with wire joints3663. The wire joints 3663 can be part of a single wire (or two) that iswrapped and bonded around all of the links 3661. The links 3661 can bemade, for example, of a high stiffness plastic, such as acrylonitrilebutadiene styrene (ABS), polycarbonate, thermoplastic polyurethane, highdensity polyethylene, PEEK, Ultem, or a mineral filled plastic. The wirecan be made, for example, of stainless steel or nitinol and can be asolid wire, a spring wire, or a multi-filament cable. Referring to FIGS.37A-C, as another example, the distal tip 3702, similar to distal tip3602, can include annular plastic links 3771 connected together withwire joints 3762. In this embodiment, however, the wire joints 3762 areshort studded segments present at each junction (i.e., not part of acontinuous wire). Referring to FIGS. 38A-38C, as another example, thedistal tip 3802 includes living hinges 3881 cut therein to allow bendingor flexing. The tip 3802 can thus be made, for example, of a cylindricalmaterial that is laser cut or by depositing different materials withrapid prototyping. In some embodiments, the tip 2802 can be made ofinjection molded polypropylene or from nitinol.

All of the distal tip embodiments shown in FIGS. 33A-38C advantageouslyhelp increase flexibility of the distal vacuum port so as to avoidhindering movement of the scope (e.g., for the section that generallyincludes steerability and/or for bending of the more proximal regions ofthe scope). Other mechanisms for increasing the flexibility of thedistal vacuum port are also possible. For example, the distal tip caninclude a coil reinforced elastomer, a braid over an angled coil cut,links made such that they can angle relative to one another while beingcaptured, or steel metal that is cut, bent, and welded with joints. Inone example, the device distal vacuum port can include a braid overlaywith a thin elastomeric or plastic sealing tube thereof. The sealingtube can be coated or plated to deliver enhanced features, such asstiffness.

Additional embodiments of the distal vacuum port are shown in FIGS.3A-6. The holes of the distal vacuum port can be circular, as shown inFIGS. 3A-3D and 5-6 or non-circular (e.g., square, oval, rectangular,hexagonal, or hexagonal with radiused corners), as shown in FIG. 4.Further, the distal vacuum port can have raised ridges around the edgesof the holes, as shown in FIG. 6, to help increase the suction force.The ridges can be made of a single material or of multiple materials andcan include flexible elastomeric and/or highly conformable flanges.Further, in some embodiments, the distal vacuum port can be slideablerelative to the endoscope rather than attached to the endoscope. In someembodiments, studs can connect the inner cylindrical portion and theouter cylindrical portion of the distal vacuum port to providestructural support therebetween.

The holes of the proximal and/or distal vacuum ports can be between 0.02inches and 0.16 inches. The hole size can be chosen to optimizeredundancy, manufacturability, vacuum strength, and ability to resistclogging from debris both externally and internally.

The distal vacuum port can include a distal tip. For Example, as shownin FIG. 2A-2B, the distal vacuum port 102 can include a rounded,atraumatic distal end 112.

Proximal Vacuum Port

The proximal vacuum port can be attached to an overtube and can beconfigured to slide relative to the endoscope.

In some embodiments, the proximal vacuum port can include a double walland vacuum chamber therebetween. Thus, Referring to FIGS. 7A-7C, theproximal vacuum port 103 can include an inner cylindrical portion 302 band an outer cylindrical portion 302 a and a sealed space 320therebetween. A plurality of holes 330 extend through the outercylindrical portion 302 a and into the sealed space 320. Further, thevacuum line 106 extends into the sealed space 320 to provide vacuumthereto. Moreover, a channel 335 can extend axially therethrough forpassage of the vacuum line for the distal port.

In other embodiments, the proximal vacuum port can include a singlewall, and creation of vacuum can occur between the wall and the scope.For example, FIGS. 40A-40C show a single walled port 4003 configured toform a vacuum chamber with the outer wall of the scope 4001. Further,the proximal vacuum port 4003 can include a seal 4040. As shown in theFIGS. 40A-40C, the seal 4040 can be a cone-shaped seal, which canadvantageously be fault tolerant to an irregular surface. As shown inFIGS. 40A-40C, in some embodiments, the seal 4040 can have the taperfacing in the distal direction. As shown in FIG. 41, in someembodiments, the seal 4140 can have a taper that faces in the proximaldirection. The seal can be made of a material, such as silicone, orthermoplastic polyurethane, that provides low drag when moved along thescope. In some embodiments, the seal can be installed in a rigidcartridge to maintain dimensional integrity. Further, the seal can helpmaintain the vacuum (i.e. avoid vacuum leaks) while allowing areas oftissue distal to the seal to be insufflated, as described further below.

Referring to FIG. 46, in some embodiments, a device 4600 can include adistal seal 4640 and a proximal seal 4646. The two seals can create acaptured volume therebetween and between the inner surface of theovertube 4604 and the outer surface of the endoscope 4601. This volumecan be filled with water and/or other fluid to provide a lubriciouslayer between the overtube 6404 and the scope 4601. The two seals 4604,4646 can keep the lubricant from leaking out during the procedure.

The holes of the proximal vacuum port can be between 0.02 inches and0.16 inches. The hole size can be chosen to optimize redundancy,manufacturability, vacuum strength, and ability to resist clogging fromdebris both externally and internally. The holes can be of a variety ofshapes, such as circular, square, oval, rectangular, hexagonal, orhexagonal with radiused corners. Further, the holes of the vacuum portcan be arranged in a variety of different patterns. For example,referring to FIGS. 7A-7C, the holes 330 can be arranged along the outercircumference of the outer cylindrical portion 302 a. The holes 330,which can be circular, can further be arranged as an array around thecircumference of the outer cylindrical portion 302 a. The axial lengthacross which the holes 330 extend can be longer for the proximal vacuumport 103 than the distal vacuum port 102. For example, in oneembodiment, there can be seven circumferential rows of holes 330 (asopposed to five for the distal vacuum port 102). The increased length ofthe area covered by holes 330 can advantageously increase the grabbingforce of the proximal vacuum port 103. Referring to FIGS. 40A-40C, theholes 4030 can be part of a single array or, as shown in FIGS. 42A-42B,the holes 4230 can be arranged a plurality of different arrays 4224 a,bseparated axially from one another. In some embodiments, the differentarrays 4224 a,b can be activated independently of one another. Forexample, the distal-most array 4224 b can be released when pushedunderneath the blocking element to prevent suctioning portion of theblocking element thereto and/or getting tissue stuck between theblocking element and the distal part of the port 4203.

The proximal vacuum port can further include a tapered distal end. Thetapered distal end of the proximal vacuum port can be longer than thetapered distal end of the distal port. Referring to FIGS. 7A-7C, in someembodiments, the tapered distal end 312 can include a plurality offlexures 313 therein configured to allow the end 312 to ride closelyover the outer diameter of the endoscope (e.g., to prevent tissue fromgetting caught between the scope and the port 103) while providingflexion at points where the outer diameter of the endoscope increases(such as at the ridge between the steerable end and the flexibleportion). Alternatively, referring to FIGS. 43A-43B, the tapered end4312 can be made of an elastomeric material so that it stays against thescope, limits pinching, goes under the blocking element, does not bendup, and does not have any cracks or crevasses that things can get caughtin.

In some embodiments, referring to FIGS. 44A-44C, the proximal vacuumport 4403 can be formed as an extension of the overtube itself (i.e.,rather than being bonded or otherwise attached thereto). Further, asshown in FIG. 45, in embodiments where the proximal vacuum port isformed as an extension of the overtube and/or in embodiments where theproximal vacuum port is a separate piece, a reinforcement coil 4554 orspring can be placed around the distal vacuum port 4503 to prevent theport 4503 from collapsing under vacuum.

In some embodiments, the proximal vacuum port can include ribs along theinner circumference thereof to help keep the port from collapsing undervacuum. For example, FIGS. 56A-D show a proximal vacuum port 5603including longitudinal ribs 5616 extending therein. The ribs 5616 arerounded so as to allow the proximal vacuum port 5603 to slide freelyalong the scope 5601. FIGS. 57A-D show a similar proximal vacuum port5703 with ribs 5716, but the holes 5730 in this embodiment are squarerather than round.

In some embodiments, referring to FIGS. 70A-70B, the proximal vacuumport 7003 can include flexible sections 7070 and rigid sections 7071along the length thereof. For example, the flexible sections 7070 andrigid sections 7071 can be in an alternative pattern along the length.The rigid sections 7071 can include the vacuum holes 7030 therein. Insome embodiments, the flexible sections 7071 can include spiraledmaterial (as shown in FIG. 70B). The vacuum port 7003 can be made, forexample, by laser cutting the vacuum holes 7030 and the spiral designinto a tube. As shown in FIG. 70A, the vacuum port 7003 can furtherinclude a tapered distal tip 7012. In some embodiments, the distal tip7012 can include a separate piece of material that is attached to therest of the port 7003. Further, the tip 7012 and/or the entire port 7003can be encased and/or coated with a material, such as urethane and/or ahydrophilic material, to help make the tip smooth and atraumatic. Theflexible sections 7070 can advantageously ensure that the proximalvacuum port 7003 flexes with the endoscope during advancement throughthe small intestine.

Blocking Element

The blocking elements described herein can be configured to expandradially (i.e., such that the overall radial dimension of the blockingelement increases from the collapsed to the expanded configuration). Theincreased radial dimension of the blocking element can prevent pleatedtissue from moving distally past the blocking element, thereby ensuringthat the tissue is properly transferred to the proximal vacuum port. Insome embodiments, the proximal vacuum port extends between 0.5 inchesand 2 inches, such as approximately 1 inch, underneath the blockingelement. The blocking element moves with the distal grabbing mechanismand in various embodiments is attached to the distal grabbing mechanismor is attached to the endoscope (or other device) to the which thedistal grabbing mechanism is attached.

Referring to FIGS. 8A-8E, in one embodiment, the blocking element 222 ofthe device 100 can include a flexure 842, a return spring 844, and arolling seal 846. The flexure 842 can be configured to attach to thedistal vacuum port 102. Further, as shown in FIGS. 8A-8E and 9A-9C, theflexure 842 can include a plurality of rigid struts 882, each with twohinges 884, 886 therein. There can be a circumferential array of struts882, such as between 6 and 12 struts, such as 9 struts. The flexure 842can be configured to bend at the hinges 884, 886 to allow the struts toextend radially outwards such that the blocking element 222 can expandto a larger overall diameter. The proximal hinge 884 can be configuredto bend inward while the distal hinge 886 can be configured to bendoutward such that a proximal wall is formed by the proximal ends 892 ofthe struts 882 when the hinges 884, 886 are bent. Further, the flexure842 can be configured to expand when axially compressed by the proximalvacuum port 103, as described further below. In some embodiments, theflexure 842 can be injection molded from polypropylene. In someembodiments, the hinges 884, 886 are living hinges.

Referring to FIGS. 8A and 11, the return spring 844 can be configured toreturn the flexure to its unexpanded neutral position. In oneembodiment, the spring 844 can sit within a groove 832 (see FIGS. 8B and8C) of the flexure 842. The spring 844 can be, for example, an elasticband or ring surrounding the struts 882. Alternatively, return springfunctionality can be obtained by making flexure 886 of a high stiffness.

Referring to FIGS. 8A-8E, the rolling seal 846 can be attached to theproximal end of the flexure 842 and can be configured to slide snuglyalong the outer diameter of the proximal vacuum port 103 when movedrelative thereto. Referring to FIG. 8A-8E and 10A-11B, the seal 846 canthus include an elastic annular member 863 and a plurality of attachmentmechanisms 865 configured to attach to attachment mechanisms 887 on theflexure 842. For example, the attachment mechanisms 887 on the flexure842 can be radially extending posts or pins while the attachmentmechanisms 865 on the rolling seal 846 can be small annular elasticrings configured to fit over the posts or pins to attach the seal 846 tothe flexure 842. The elastic annular member 863 can be configured tostretch radially as it slides along the tapered distal surface 312 ofthe proximal vacuum port 103. In one embodiment, the rolling seal 846can be cast from urethane. Alternatively, the rolling seal 846 can beattached to the flexure 842 by insert molding them together.

Referring to FIGS. 12A-12G, the position of blocking element 222 isfixed with respect to the position of distal vacuum port 102. Theblocking element 222 can be activated (i.e., radially expanded) throughaxial relative movement between the proximal vacuum port 103 and distalvacuum port 102. In an initial configuration, shown in FIG. 12A, theproximal vacuum port 103 can be in a retracted position relative to theblocking element 222 and distal vacuum port 102. The proximal vacuumport 103 and distal vacuum port 102 can then be moved axially towardeach other to place proximal vacuum port 103 into contact with theblocking element 222, as shown in FIG. 12B. Referring to FIG. 12C, asthe proximal vacuum port 103 is pushed against the seal 846, it causesthe flexure 222 to bend at hinges 884, 886 such that the distal portions892 extend radially outwards. As shown in FIG. 12D, once the flexure 222is fully expanded through movement of the hinges 884, 886, the proximalvacuum port 103 and distal vacuum port 102 can continue to be movedaxially toward each other, forcing the tapered end 312 to slideunderneath the seal 846. The flexure 222 can thus continue to expand asthe seal 846 moves along the taper 312 and over the holes 330 of theproximal vacuum port 103. Relative axial movement of the proximal vacuumport 103 with respect to distal vacuum port 102 can continue until theproximal vacuum port 103 hits the proximal end of the distal vacuum port102 and/or until the holes 330 of the proximal vacuum port 103 are fullycovered by blocking element 222. Referring to FIG. 12E, as the vacuumport 103 and blocking element 222 move apart, the diameter of theblocking element 222 will decrease due to the radially inward forceprovided by the return spring 844. The proximal vacuum port 103 can thenbe fully retracted, as shown in FIGS. 12F-12G.

Additional embodiments of blocking elements are shown in FIGS. 13A-18Dand 28. In the embodiment of FIGS. 13A-13B, a blocking element 1322includes rigid linkages 1313 configured to pivot. An o-ring 1314 keepsthe blocking element 1322 in the constrained configuration. The linkages1313 can be configured to pivot out and increase their diameter uponactivation by axial movement of the proximal vacuum port. In theembodiment of FIGS. 14A-B, the blocking element 1422 can be similar toFIG. 1322, but can be entirely elastomeric. The blocking element 1422can flex or stretch. In the embodiment of FIG. 15, the blocking element1522 can include linkages 1513 that can be directly integrated into thedistal vacuum port. In the embodiment of FIGS. 16A-16D, the blockingelement 1622 can include both rigid regions and flexing regions. In theembodiment of FIG. 17, the blocking element 1722 can include aninflatable cuff 1717. In the embodiment of FIG. 18, the blocking element1822 can include a sheath, such as a braided sheath, that is configuredto compress to create radial expansion when activated by axial movementof the proximal vacuum port. The braids can be configured to moverelative to one another and/or can be welded or attached at some or allcross-over points. The blocking element 1822 can advantageously beflexible, smooth, small, and simple. The braids and linkages can becreated with continuous outer skin such that there are no pinch points.In the embodiment of FIG. 28, the blocking element and distal vacuumport are combined into a single integrated structure. As shown, in suchan embodiment, the vacuum holes can be positioned along the struts ofthe blocking element.

Another exemplary blocking element 5222 is shown in FIGS. 52A-52F. Theblocking element 5222 is activated with contact from the proximal vacuumport, as described with reference to blocking element 222 and includes aplurality of links 5252 a-e at a proximal end of a tube 5253. Thelinkages 5252 a-e can be configured to pivot such that the tips of thelinkages 5252 a-e rotate from a distal position that is flush with thetube 5253 (FIGS. 52A-C) to a proximal position that extends radiallyoutward from the tube 5253 (FIGS. 52D-F). In some embodiments, a springmechanism can be configured to hold the links 5252 a-c down when in thecollapsed position.

In some embodiments, the blocking element can be an inflatable element,such as a balloon. For example, FIGS. 39A-D show a balloon blockingelement 3922 (FIGS. 39C-D show a balloon blocking element 3922 deflatedwhile FIGS. 39A-B show the balloon blocking element 3922 inflated). Theballoon 3922 is advantageously soft and atraumatic so as to avoiddamaging tissue as the device travels therethrough. In some embodiments,the balloon 3922 can be a compliant balloon. In other embodiments, theballoon can be non-compliant. As shown in FIGS. 39A-39B, the balloonblocking element 3922, when inflated, can have a larger radius than thescope 3901. Further, in some embodiments, the radius of the proximalportion of the balloon can be greater than the radius of the distalportion of the balloon. For example, the balloon can have a conicalshape. The balloon can be symmetrical about the scope 3901 so as to helpcenter the scope during transfer through the lumen.

Further, in some embodiments, the blocking element is separate from thedistal vacuum port (i.e., not integral therewith). For example,referring to FIGS. 39A-39D, the device 3900 can include a balloonblocking element 3922 that is separated from the distal port 3902.Separating the blocking element 3922 from the distal port 3902advantageously allows the blocking element 3922 to be placed proximal tothe steering section of the scope 3901, thereby improving docking of theproximal port within the blocking element 3922. Thus, as shown in FIG.39A, the balloon blocking element 3922 can be configured to sit directlyproximal to the bump 3992 on the scope 3901.

Any of the blocking elements described herein can include a wipingelement on a proximal end thereof configured to facilitate movement ofpleated tissue over the proximal vacuum port while ensuring that none ofthe tissue gets pinched thereunder during relative movement between theproximal vacuum port and the blocking element. For example, referring toFIG. 32G, the balloon blocking element 3222 is attached over a wiperelement 3250 that includes a rigid sleeve 3261 and a plurality offlexures 3293 at a proximal end thereof. The flexures 3293 expandoutward when the proximal port is moved thereagainst such that theproximal port can move within the space 3265 to dock within the blockingelement 3222. The blocking element 3222 can be attached to the scopewith a friction fit.

As yet another example, referring to FIGS. 58A-C, the balloon blockingelement 5822 is attached over a wiper element 5850 (see FIG. 58C) thatincludes an elastomeric sleeve 5891 reinforced with coil. The coilreinforced sleeve 5891 advantageously prevents collapse under vacuumwhile allowing some flexibility without buckling when bent. The wiperelement also includes flexures 5893 that extend outwards, similar toflexures 3293. A bayonet fitting 5882 on the distal end twists into therest of the unit and compresses the conical piece thereunder to keep theunit in place proximal to the bump in the scope.

As yet another example, referring to FIGS. 50A-F, the blocking element5022 (the radially expandable elements of the blocking element 5022,such as the balloon, are not shown for clarity) includes wiping element5050. Wiping element 5050 includes a plurality of flexures 5093configured to expand (FIGS. 50D-E) or contract (FIG. 50A-C) whenextending over the proximal vacuum port when it extends thereunder. Anelastomeric o-ring 5095 at the proximal end holds the proximal ends ofthe flexures 5093 together and expands and contracts with the flexures.FIGS. 51A-51F show another embodiment of a blocking element 5122 (again,radially expandable elements, such as the balloon, are not shown forclarity) with wiping element 5150. Wiping element 5150 includes flexures5193 that are similarly configured to expand and contract. In thisembodiment, flexures 5193 are hinged. FIGS. 51A-51C show the flexures4193 expanded while FIGS. 51D-F show the flexures contracted.

Other embodiments of wiping elements are possible. For example, thewiping elements can include Teflon segments, coated o-rings, hinged upsegments, coil springs, or iris style. In some embodiments, the wipingelements can further include a low friction coating or be made of amaterial that is inherently low friction (such as polypropylene, Teflon,or FEP). The wiping elements can be configured such that there isminimal contact with the proximal vacuum port so as to reduce friction.For example, only the o-ring and/or only the tips of the flexures cantouch the proximal vacuum port as it passes thereunder.

In some embodiments, when the blocking element is a balloon, inflationof the balloon blocking element can occur by inflation through analready existing inflation port on the scope. For example, as shown inFIG. 32A, an inflation port 3292 from the endoscope 3201 can be sealedoff using o-rings 3271 a,b to provide inflation to the balloon blockingelement 3222. A close-up of the inflation port 3292 with surroundingo-rings 3271 a,b can be seen in FIG. 32F.

In embodiments where the balloon blocking element is moved distally, aline can be run from the inflation port to the blocking element forinflation. For example, FIGS. 39A-D show an inflation line 3939extending from the distal end of the scope's inflation port back to theballoon blocking element 3922.

In other embodiments, the balloon blocking element can be inflatedthrough an inflation line (e.g., a telescoping inflation line) that runsdown the working channel of the scope or through an inflation lineextending through an overtube or alongside the outer circumference ofthe scope.

Referring to FIGS. 47A-I, in some embodiments, an extendable tube orneedle 4774 (see FIG. 47B) can be attached to the proximal port 4703 toaid with inflation of the balloon blocking element 4722. Thus, theneedle 4774 can be stored within the wall of the proximal port 4703(FIG. 47C). When the proximal port 4703 is fully within the blockingelement 4722, the needle 4774 can extend outwards to provide access tothe inflation port 4792 (FIG. 47D), and fluid can be supplied throughthe needle 4774 and port 4792 to inflate the balloon blocking element4722 (FIG. 47E). The needle can then be withdrawn back into the proximalport 4703 (FIG. 47F). FIGS. 47H-I show a cross-section of the distal endof the proximal port 4703, which can include a plurality of self-sealingholes 4747 for transfer of a plurality of needles therethrough.

A similar embodiment is shown in FIGS. 48A-D. The distal end of theproximal port 4803 can include a solid rubber element rather than anarray of holes. The needle 4874 can be used to pierce through the rubberelement to inflate the blocking element 4822.

In other embodiments, the balloon blocking element can be inflatedthrough an annular channel formed between an additional overtube and thescope. That is, referring to FIG. 66A-H, a device 6600 can include aballoon blocking element 6622 attached to an additional overtube 6666that extends through the handle 6607 to the balloon blocking element6622. An annular space or lumen 6667 is created between the overtube6666 and the scope 6601 through which a fluid or gas can be supplied tothe balloon blocking element 6622 (e.g., through balloon inflation entryport 6669). An insufflation supply port 6668 communicating with annularspace or lumen 6667 can be positioned on the overtube 6666 and/or beconfigured as part of the handle 6607. This embodiment also has tissuegrabbing mechanisms (distal vacuum ports 6602 and proximal vacuum ports6603) as discussed above with respect to other embodiments.

The blocking elements herein are described as expanding radially. Suchradial expansion includes any increase in overall radius from thecollapsed configuration to the expanded configuration, regardless of theprocess or direction of expansion. Thus, for example, referring to FIG.69A, a blocking element 6922 a might extend purely in the radialdirection. Further, as shown in FIG. 69B, a blocking element 6922 bmight extend in a tangential direction while still resulting in anoverall radially expansion. Likewise, as shown in FIG. 69C, a blockingelement 6922 c might extend in a rotational direction while resulting inan overall radial expansion.

Overtube Design

Referring back to FIGS. 1A-1C, the overtube 104 can be configured toride over an endoscope 101 and can attach to the proximal vacuum port103. Further, referring to FIGS. 19A-19D, the overtube can be designedto include a plurality of lumens configured to hold the endoscope andthe vacuum lines 105, 106 therein.

For example, as shown in FIGS. 19A, an overtube 1904 can be amulti-lumen extrusion with a large central lumen 1921 for the endoscope,a side lumen 1923 for one of the vacuum lines 105, 106, and a separatetube 1925 attached thereto for the other vacuum line 105, 106. Theovertube 1904 can advantageously allow for the union of differentstructures made of different materials, thereby potentially providing aneffective composite structure (for example, one that has very high pushstiffness, but very low bending stiffness).

Referring to FIG. 19B, an overtube 2004 can include a single lumenextrusion with a lumen 2021 for the endoscope and two separate tubes2035, 2033 attached for the vacuum lines 105, 106. The two separatetubes 2035, 2033 can be inside of the lumen 2021, as shown, or outside.Further, the shape of the lumen 2021 or the outer diameter of the tube2004 can be modified to include grooves or channels/indents for theseparate tubes 2035, 2033.

Referring to FIG. 19C, the overtube 2104 can be a multi-lumen extrusionwith a large central lumen 2121 for the endoscope and two lumens 2145,2145 for the vacuum lines 105, 106.

Finally referring to FIG. 19D, the overtube 2204 can include a largecentral lumen 2221 for the endoscope and redundant smaller lumens 2245a-d in the wall thereof for the vacuum lines. Redundant lumens canadvantageously ensure a working vacuum even if one of the lumens becomesclogged.

Vacuum Connection to Distal Port

The distal vacuum port can be connected to vacuum through vacuum linesrunning down the side of the scope (such as a telescoping line), througha tube extending down the working channel, or through vacuum applied tothe working channel itself.

Referring to FIGS. 1A and 1C, in some embodiments, the vacuum tube 105connected to the distal vacuum port can be a telescoping tube thattelescopes within the overtube 104 to allow for movement of the distalvacuum port 102 and endoscope 101 relative to the handle 107 and/orvacuum supply.

Referring to FIGS. 20A-23, the telescoping vacuum tube 105 can beattached to the endoscope 101 to ensure that the proximal vacuum portcan move easily thereover. The attachment mechanism can be configuredto: (1) hold the tube 105 against the endoscope 101; (2) slide freelyrelative to the proximal vacuum structure and small intestine; (3)prevent lateral movement of the vacuum tube 105; and/or (4) be easy toinstall. Exemplary methods of attachment are shown in FIGS. 20A-23.Referring to FIGS. 20A-20B, the vacuum tube 105 can be attached to theendoscope 101 with an adhesive, such as tape (e.g., bonded orheat-sealed). Referring to FIGS. 21A-21C, the tube 105 can be attachedto the endoscope 101 with a coil 2072. The coil 2072 can extend all theway around the endoscope 101 or partially around the endoscope 101. Thecoil 2072 can be made, for example, of stainless steel (e.g., 0.007″),Nitinol or plastic. Referring to FIG. 22, the vacuum tube 105 can beshrunk onto the endoscope 101, such as activated by heat, chemistry, orUV light. Finally, referring to FIG. 23, the tube 105 can be sealed viaa stretchable material 2372 that rolls over the endoscope 101 and tube105, such as made of urethane or latex.

Referring to FIG. 24A, in some embodiments, the vacuum line 105 canextend from the distal vacuum port 102 for entry into the workingchannel of the endoscope 101. In this embodiment, the vacuum line 105can coil around the tip of the endoscope 101 so as to not disturb thetip flexure. In embodiments where the distal vacuum port is mounted atthe tip, the vacuum line can directly enter the working channel.Further, the working channel can be used to provide vacuum to the vacuumline 105. At the exit, there can be a flapper valve that is normallyclosed to maintain a vacuum path, but can be pushed open by aninstrument so that the working channel can still function as aninstrument working channel. In other embodiments, referring to FIG. 24B,the vacuum line 105 can extend from the distal vacuum port 102proximally towards the handle.

Referring to FIG. 32A, in some embodiments, the working channel 3233itself can be used to provide vacuum through channel 3297. A valve 3232in an opening in end cap 3296, such as a duckbill valve, prevents thevacuum from pulling out the distal end of the channel 3233, but stillallows a working element to travel therethrough. Another embodiment of adistal tip 5502 with a duckbill valve 5532 is shown in FIGS. 55A-55C.

Handle

The devices described herein can have handles, actuators or controls foractivating the grabbing mechanisms and/or blocking elements.

For example, referring to FIGS. 25A-25C, a handle 107 can include ahandle body 2510 having a distal opening 2505 configured to mount to theovertube. The handle 107 can further include a large central lumen 2504configured to ride over the endoscope and a vacuum attachment 2502. Thehandle 107 can further include a spool valve assembly 2508 configured tocontrol the release of vacuum to either the proximal vacuum line or thedistal vacuum line, respectively, through vacuum lumen connections 2507a,b. User-activated buttons 2503 a,b can be configured to interface withthe spool valve assembly 2508 to manually control the release of vacuum.Vents 2509 a,b can also be positioned within the system to releasevacuum pressure substantially instantly when the vacuum is released.

As shown in FIGS. 26A-26C, the handle 107 can be configured to fiteasily in the user's hand. Further, the handle 107 can be designed toallow the user to both hold the handle and activate the buttons 2503 a,bwith a single hand.

In some embodiments, the vacuum input 2502 can be removed to provideflush-through. In other embodiments, the handle 107 can include aseparate flush port with a valve for the vacuum line.

The spool valve assembly 2508 is shown in more detail in FIGS. 27A-27B.The spool valve housing 2648 includes annular or toroidal grooves orrings 2601, 2602, 2603, 2604, 2605. Further, annular grooves 2610, 2612,2614 can extend along the spool 2638. Each ring can be connected to adifferent component of the system. For example, ring 2601 can beconnected to a first vent 2509 a, ring 2602 can be connected to thevacuum lumen 2507 a for the distal vacuum port, ring 2603 can beconnected to the vacuum input 2502, ring 2604 can be connected to thevacuum lumen 2507 b for the proximal vacuum port, and ring 2605 can beconnected to a second vent 2509 b. Thus, referring to FIG. 27A, when thebutton 2503 a is pushed all the way in, a first connection is madebetween the annular ring 2603 (connected to vacuum input 2502) and theannular ring 2604 (connected to the vacuum lumen 2508 b for the proximalvacuum port) via groove 2612 and a second connection is made betweenannular ring 2601 (connected to first vent 2509 a) and annular ring 2602(connected to the vacuum lumen 2507 a for the distal vacuum port) viagroove 2610. As a result, vacuum can be applied to the proximal vacuumport and a vent can be applied to the distal vacuum port. In contrast,referring to FIG. 27B, when the button 2503 b is pushed all the way in,a first connection can be made between ring 2602 (connected to thevacuum lumen 2507 a for the distal vacuum port) and ring 2603 (connectedto vacuum input 2502) and via groove 2612 a second connection can bemade between 2604 (connected to the vacuum lumen 2508 b for the proximalvacuum port) and 2605 (connected to second vent 2509 b) via groove 2614.As a result, the vacuum can be applied to the distal vacuum port whilethe proximal vacuum port is vented.

Another exemplary handle 5307 is shown in FIGS. 53A-53H. The handle 5307can include a spool mechanism 5359 configured to connect the proximalvacuum port to the vacuum source. Thus, as shown in FIG. 53A, the spoolmechanism 5359 can include a vacuum input chamber 5331, a proximalvacuum chamber 5332 connected to a second vacuum port, and a thirdchamber 5333 configured to vent to atmosphere. A spool 5336 can be movedproximally and distally using button 5353 (through connection 5354).FIG. 53A thus shows the spool 5356 configured such that chambers 5331and 5332 are connected together, thereby allowing vacuum to be appliedto the proximal vacuum port through line 5355. In contrast, FIG. 53Bshows that chambers 5332 and 5333 are connected together, therebyplacing deactivating the proximal vacuum port (and venting toatmosphere).

In this embodiment, vacuum to the distal port is supplied through theworking channel of the endoscope. As such, control of vacuum through thedistal vacuum port can be performed through a button or vacuumactivation mechanism on the scope itself.

FIGS. 54A-D show an alternative embodiment of a handle 5407 that can beused to control vacuum to the proximal vacuum port. In this embodiment,the handle 5407 includes three chambers 5431 (for the vacuum input),5432 (for the proximal vacuum port), and 5433 (for venting toatmosphere). A u-channel 5455 moves back and forth with the button 5453to connect the chambers as desired. FIG. 54C thus shows the suction off(chamber 5432 for vacuum port connected to chamber 4333 for venting tothe atmosphere). In contrast, FIG. 54D shows suction/vacuum on (chamber5431 for vacuum input connected to 5432 for proximal vacuum port).

In Use

The devices described herein can be used to quickly and efficiently movean endoscope through the small intestine.

For example, referring to FIGS. 29A-E, the device 100 can first beconnected to an inner element the use wishes to advance through thegastrointestinal tract (or other lumen), such as endoscope 101. Tobegin, referring to FIG. 29A, the endoscope 101 can be placed throughthe handle 107. As shown in FIG. 29B, the endoscope 101 can be advancedthrough the overtube 104 until the endoscope 101 exits the overtube 104,and the handle 107 is near the endoscope 101 proximal end. As shown inFIG. 29C, the telescoping line 105 can then be attached to the endoscope101 (e.g., to avoid tangling during use). As shown in FIG. 29D, thedistal tip 102 can then be attached to the endoscope 101. Finally, asshown in FIG. 29E, vacuum can be attached to the vacuum input 2502 onthe handle 107.

Once set up (as shown in FIGS. 29A-29E), the endoscope 101 and attacheddevice 100 can be inserted into the small intestine, such as orally oranally (as shown in FIGS. 30A-30H). As shown in FIG. 30A, the endoscope101 and device 100 can be advanced to the start of the small intestine3001. As shown in FIG. 30B, the distal vacuum port 102 of the device 100and endoscope 101 can then be advanced further into the small intestine3001, such as about 18 to 24 inches, by pushing forward on theendoscope. The distal vacuum port 102 can then be activated to suctiontissue of the small intestine 3001 thereto, as shown in FIG. 30C. Asshown in FIG. 30D, the space between the distal vacuum port 102 and theproximal vacuum port 103 can be reduced until the proximal vacuum porthits the blocking element 222 by pulling on the proximal end of theendoscope. As this relative motion between the vacuum portions 102, 103occurs, tissue of the small intestine 3001 is pleated. Referring to FIG.30E, the distal vacuum port 102 can continue to be pulled proximallyover the proximal vacuum port 103, causing the blocking element 222 toradially expand. As the blocking element 222 expands, a wall is createdthat blocks the tissue pleats from moving distally over the distalvacuum port 102. Further, as the distal vacuum port 102 is pulledproximally, the proximal vacuum port 103 moves fully inside of theblocking element 222, causing the pleats to move proximal of theproximal vacuum port 103. Referring to FIG. 30F, the proximal vacuumport 103 can then be activated and the distal vacuum port 102 released.As shown in FIG. 30G, the distal vacuum port 102 can then be pusheddistally through the tissue of the small intestine 3001 about 18 to 24inches as the proximal vacuum port 103 holds the tissue. Referring toFIG. 30H, once the distal vacuum port 102 is in place, the distal vacuum102 can be activated and the proximal vacuum 103 released, and the stepscan be performed again until the endoscope 101 has reached the desiredlocation, such as until the endoscope has traveled the entire length ofthe small intestine. It should be understood that although describedherein as be performed by moving the distal vacuum port 102 distally orproximally, the proximal vacuum port 103 can also be moved proximally ordistally to obtain the same relative motion between the two port 102,103 and provide advancement of the scope through the small intestine.

As another example, referring to FIGS. 31A-31F, the device 3100 workssimilarly to device 100 for advancement of the scope 3100 through thelumen 3131. Thus, at FIG. 31A, the device 3100 is inserted into thelumen 3131 in the distal direction (indicated by the arrow) while theballoon blocking element 3122 is deflated and the vacuum ports 3102,3104 are deactivated. At FIG. 31B, the balloon blocking element 3122 isinflated (and can remain inflated throughout the entire procedure). Thedistal vacuum 3102 is then activated, thereby suctioning tissue of thelumen 3101 against the distal port 3102 (and pulling vacuum on the lumen3131 distal to the distal port 3102). At FIG. 31C, the proximal vacuumport 3103 and distal vacuum port 3102 are moved towards one anotherwhile the distal vacuum port 3102 is activated. The expanded blockingelement 3122 prevents the tissue of the lumen 3131 from travelingdistally past the blocking element 3122 and/or the distal vacuum 3102,thereby creating pleats 3133 of tissue in the lumen. At FIG. 31D, theblocking element 3122 is slid over the proximal vacuum port 3103 so asto transfer the pleats 3133 proximal of the proximal vacuum port 3103.At FIG. 31E, the vacuum on the distal vacuum port 3102 is released, andthe vacuum on the proximal vacuum port 3103 is activated, therebysuctioning tissue of the lumen 3131 thereto (distal to the pleats 3133).As shown at FIG. 31F, the distal vacuum port 3102 can then be movedfurther distally through the lumen 3131. The process can then berepeated so as to incrementally move the device scope 3101 and device3101 distally through the lumen 3131.

Visual Indicator

In some embodiments, the device can include a visual indicator thereonto indicate a state of the device (e.g., vacuums on/off, ballooninflated/deflated, proximal vacuum port fully docked inside of theballoon blocking element, etc.). For example, a “red out” in the scopeviewer can indicate that the distal tip vacuum port is on (i.e., causingthe tissue to suction to the scope lens). Further, referring to FIGS.49A-B, in some embodiments, an indicator element 4991 on the distalvacuum port 4902 can be configured to be pushed distally when theproximal vacuum port 4903 is fully docked or positioned within theballoon blocking element 4922 (thus indicating that all of the pleatedtissue had been pushed proximal to the proximal vacuum port 4903,similar to as shown in FIG. 31D). In some embodiments, a spring, such asa coil spring, wave spring, local compression spring, or “hit plate” canpush the element 4991 distally when acted upon by the proximal vacuumport 4903. In some embodiments, the indicator element 4991 acts as avisual indicator that docking is complete by being positioned over thecamera of the scope so as to be viable in the resulting image. In someembodiments, the indicator element 4991 acts as a visual indicator thatdocking is complete by moving the tissue off of the end of the scope,thereby locally lifting off red-out tissue. FIG. 49A thus shows that theproximal vacuum port 4903 is not fully docked while FIG. 49B shows thatthe proximal vacuum port 4903 is fully docked. Another example of anindicator includes an electronic indicator, such as an LED that light upwhen sensors (e.g., magnetic sensors or hall sensors) on the proximalvacuum port and the distal vacuum port are in proximity. Yet anotherexample of an indicator includes a magnetic indicator arranged such thata magnet on the proximal vacuum port and a magnet on the distal vacuumport, when in proximity, repel or attract to create a change in theimage seen distal to the camera. The visual indicator can be areciprocating cable that is flexible, extending through a tube that iscoiled around the scope's shaft and extending to its exit at the distalend of element 4902.

Additional Embodiments

Although the devices described herein has been described as including adistal vacuum port that is attached to the endoscope, other set-ups arepossible. For example, FIG. 59 shows a device 5900 that includes just asingle vacuum port 5902 attached to an overtube 5904. FIG. 60 shows adevice including two overtubes that slide relative to one another. Thedistal vacuum port 6002 is attached to an inner overtube 6004 a whilethe proximal vacuum port 6003 is attached to an outer overtube 6004 b.

Various set-ups for a dual overtube system (as shown in FIG. 60) can beused, as shown in FIGS. 61A-C. Referring to FIG. 61A, the inner andouter overtubes 3204 a,b can be multi-lumen extrusions. The innerovertube 6104 a includes a central lumen 6121 for the endoscope and aside lumen 6123 for one of the vacuum lines 105, 106. The outer overtube6104 b can extend therearound and have lumens 3343 a,b that extend oneither side of the lumen 6123 for redundant vacuum lines. FIG. 61B issimilar to the set-up of FIG. 61A, but includes an in-laid reinforcingcoil 6133 in the inner tube 6104 a. FIG. 61C is likewise similar, butincludes only a single outer overtube lumen 6143.

Referring to FIGS. 62A-B, rather than having vacuum ports that aremovable relative to one another, a device 6200 can include one or moremovable planar vacuum belt 6234. The movable planar vacuum belt 6234 canroll over a cylindrical feature 6236 a,b at either end, e.g., similar toa tank tread or conveyor belt, to create a perforated belt through whichvacuum is drawn. As the belt 6234 is turned (for example, by turning atoothed cog into mating female features in the belt's surface), tissuethat is suctioned to the belt can be moved along with the belt 6234,thereby moving tissue along the device (and/or the device through thetissue). The scope can be configured to go through a central lumen 6230.The device 6200 can include a plurality of vacuum belts arrangedcircumferentially therearound. For example, as shown in FIGS. 62A-B,there can be four different vacuum belts.

Referring to FIGS. 63A-63B, a device 6300 can include a distal vacuumport that has a plurality of sections 6302 a,b,c,d that can moverelative to one another. For example, a first set (sections 6302 a,c)can move axially relative to a second set (sections 6302 b,d). Likewise,vacuum can be applied to each set alternatively to move through thetissue.

Referring to FIG. 64, in some embodiments, one or more balloons 6406 canbe used in place of the vacuum ports. In some embodiments, the balloonscan act as gripping mechanisms on their own rather than using vacuum. Inother embodiments, the balloons can include an inner wall to holdpressure, an outer wall that is perforated, and an intermediate spacetherebetween that can be maintained by spacers. As the balloon isinflated, it can expand to contact the tissue of the intestine. At thatpoint, the vacuum can be turned on, pulling vacuum into the intermediatespace and out the perforations. As a result, tissue can be suctioned tothe outside of the balloon, enabling subsequent manipulation. In anotherembodiment, the inner wall of the balloon can include an outward forcecreated by springs, including wire that is pre-set to an outwardgeometry. As the springs are released, the diameter increased, thesurface is brought out to the tissue, and then the vacuum can be turnedon to suction the tissue onto the outside surface. FIG. 68 shows anotherdevice 6800 wherein the proximal vacuum port has been replaced with aballoon 6886. The balloon 6886 is still configured to fit radiallywithin the blocking element 6822.

Although the devices herein have been described as being used over anendoscope, the devices can also be configured as a discrete unit thatfunctions independently without having to utilize a pre-existingendoscope. The discrete unit can function untethered (i.e., withon-board elements) or tethered (with an umbilical). In some embodiments,the umbilical can have a feature that allows it to unspool as it isadvanced, such that the umbilical is not dragged nor subject to notablecapstan drag forces relative to the small intestine that the unit weavesthrough as it advances through the small intestine.

Although the grabbing mechanisms of the devices described herein havebeen described as moving relative to one another by manual activation,other activation mechanisms are possible, such as with bellows, a motor,or a pneumatic/hydraulic actuator.

In embodiments where one or more of the grabbing mechanisms are vacuums,vacuum lines can extend from the port(s) back to a vacuum source. Tomodulate the attachment force and physiological tissue response, vacuumpressure and flow rate can be modulated. For example, the system canoperate at or near full vacuum (760 mm Hg) or at partial vacuum (600,500, 300, 250, 120, 50 mmHg). Vacuum can be applied continuously orintermittently. Flow rates can be varied, for example, from 10 to 40 to100 liters per minute.

In embodiments where the blocking element is an inflatable element orballoon and one or more vacuum ports are used as the grabbingmechanisms, the balloon can be configured to stay inflated throughoutthe entire procedure. Doing so can advantageously create two zones—aproximal zone proximal to the inflated balloon and a distal balloon thatis distal to the inflated balloon. The proximal zone can be under vacuum(by the vacuum ports) while the distal zone can be insufflated (such aswith an insufflator). Having the proximal zone under vacuum canadvantageously help with pleating of the tissue while having the distalzone insufflated can advantageously increase visibility through the lensof the scope within the lumen.

In some embodiments, referring to FIG. 67, a device 6700 with a balloonblocking element 6722 (or other type of blocking element) can furtherinclude an inflatable element or balloon 6776 attached to the distal endof the proximal vacuum port 6703, thereby preventing vacuum from movingdistal to the balloon 6776.

It should be understood that any feature described with respect to oneembodiment herein can be replaced or supplemented with any featuredescribed with respect to any other embodiment described herein.

System Layout

Referring to FIG. 65, the devices described herein can be connected to avariety of different control components. For example, the device 100 (orany other device described herein) can be positioned over the endoscope101, which can be attached to a monitor 10, a video processor 6512, atip wash 6516, instruments 6518 for use therewith, a pressurized air orinsufflation source 6501, and a vacuum source 6505. The device 100 canlikewise be connected to the vacuum source through a suction fluidcollection canister and line 6503.

Conclusions

Additional details pertinent to the present invention, includingmaterials and manufacturing techniques, may be employed as within thelevel of those with skill in the relevant art. The same may hold truewith respect to method-based aspects of the invention in terms ofadditional acts commonly or logically employed. Also, it is contemplatedthat any optional feature of the inventive variations described may beset forth and claimed independently, or in combination with any one ormore of the features described herein. Likewise, reference to a singularitem, includes the possibility that there are a plurality of the sameitems present. More specifically, as used herein and in the appendedclaims, the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

What is claimed is:
 1. A method of advancing a device through thegastrointestinal tract, comprising: inserting a device comprising firstand second ports into the gastrointestinal tract; advancing the firstport distally through the gastrointestinal tract away from the secondport; sliding the second port towards the first port; moving tissueproximally past the second port using a blocking element that ispositioned proximal to the first port; activating vacuum through thesecond port to suction tissue of the gastrointestinal tract to thesecond port; and advancing the first port distally through thegastrointestinal tract while the vacuum is activated through the secondport.
 2. The method of claim 1, further comprising sliding the blockingelement over the second port before activating vacuum through the secondport.
 3. The method of claim 1, wherein the blocking element comprises aballoon.
 4. The method of claim 1, further comprising expanding theblocking element.
 5. The method of claim 4, further comprising keepingthe blocking element expanded during all of the advancing, sliding,preventing, and activating, steps.
 6. The method of claim 1, furthercomprising repeating the steps of sliding, preventing, activating, andadvancing the first port distally through the gastrointestinal tractwhile the vacuum is activated through the second port.
 7. The method ofclaim 6, further comprising repeating the steps until the device isentirely through a small intestine of the gastrointestinal tract.
 8. Themethod of claim 1, further comprising inserting a scope into the deviceto advance the scope through the gastrointestinal tract as the deviceadvances through the gastrointestinal tract.
 9. A method of advancing adevice through the gastrointestinal tract, comprising: inserting adevice having a first grabbing mechanism and a second grabbing mechanisminto the gastrointestinal tract; activating the first grabbing mechanismto grab tissue of the gastrointestinal tract; moving the first andsecond grabbing mechanisms towards each other; using a blocking elementto urge tissue of the gastrointestinal tract proximal to the secondgrabbing mechanism during the moving step; activating the secondgrabbing mechanism to grab tissue of the gastrointestinal tract;deactivating the first grabbing mechanism; and advancing the firstgrabbing mechanism distally while the second grabbing mechanism isactivated.
 10. The method of claim 9, wherein at least one of the firstand second grabbing mechanisms is a vacuum port.
 11. The method of claim9, further comprising sliding the blocking element over the secondgrabbing mechanism before activating the second grabbing mechanism. 12.The method of claim 11, wherein sliding the blocking element over thesecond grabbing mechanism urges pleated tissue of the gastrointestinaltract proximally over the second grabbing mechanism.
 13. The method ofclaim 9, wherein the blocking element comprises a balloon.
 14. Themethod of claim 9, further comprising expanding the blocking element.15. The method of claim 14, further comprising keeping the blockingelement expanded during all of the steps of activating the firstgrabbing mechanism, moving, preventing, activating the second grabbingmechanism, deactivating, and advancing steps.
 16. The method of claim 9,further comprising deactivating the second grabbing mechanism afteradvancing the first grabbing mechanism distally.
 17. The method of claim16, further comprising repeating the steps of activating the firstgrabbing mechanism, moving, preventing, activating the second grabbingmechanism, deactivating the first grabbing mechanism, advancing thefirst grabbing mechanism, and deactivating the second grabbingmechanism.
 18. The method of claim 17, further comprising repeating thesteps until the device is entirely through a small intestine of thegastrointestinal tract.
 19. The method of claim 9, further comprisinginserting a scope into the device to advance the scope through thegastrointestinal tract as the device advances through thegastrointestinal tract.
 20. A method of advancing a device through thegastrointestinal tract, comprising: inserting a device having a firstgrabbing mechanism and a second grabbing mechanism into thegastrointestinal tract; activating the first grabbing mechanism to grabtissue of the gastrointestinal tract; moving the first and secondgrabbing mechanisms towards each other to create pleats of tissuetherebetween; moving the pleats of tissue proximal to a portion of thesecond grabbing mechanism; activating the second grabbing mechanism tograb tissue of the gastrointestinal tract that is distal tosubstantially all of the pleats of tissue; and advancing the firstgrabbing mechanism distally while the second grabbing mechanism isactivated.
 21. The method of claim 20, wherein at least one of thegrabbing mechanisms is a vacuum port.
 22. The method of claim 20,further comprising moving tissue proximally past the second grabbingmechanism using a blocking element that is positioned proximal to thefirst grabbing mechanism.
 23. The method of claim 22, further comprisingsliding the blocking element over the second grabbing mechanism beforeactivating the second grabbing mechanism.
 24. The method of claim 23,wherein sliding the blocking element over the second grabbing mechanismurges pleated tissue of the gastrointestinal tract proximally over thesecond grabbing mechanism.
 25. The method of claim 22, wherein theblocking element comprises a balloon.
 26. The method of claim 22,further comprising expanding the blocking element.
 27. The method ofclaim 26, further comprising keeping the blocking element expandedthroughout all of the steps of activating the first grabbing mechanism,moving the first and second grabbing mechanisms, moving the pleats oftissue, activating the second grabbing mechanism, and advancing thefirst grabbing mechanism.
 28. The method of claim 20, further comprisingrepeating the steps of activating the first grabbing mechanism, movingthe first and second grabbing mechanisms, moving the pleats of tissue,activating the second grabbing mechanism, and advancing the firstgrabbing mechanism.
 29. The method of claim 28, further comprisingrepeating the steps until the device is entirely through a smallintestine of the gastrointestinal tract.
 30. The method of claim 20,further comprising inserting a scope into the device to advance thescope through the gastrointestinal tract as the device advances throughthe gastrointestinal tract.
 31. The method of claim 20, wherein movingthe pleats of tissue proximal to a portion of the second grabbingmechanism comprises sliding an element of the device over the secondgrabbing mechanism.